Regulatory Digest

For many years, global implementation of post approval changes often required seven or more years, delaying access to improved manufacturing methods. Through various reliance initiatives and collaborative efforts, the timeline has already been reduced to three to five years. Genentech now aims to further accelerate global approval timelines to approximately 18 months.

ISPE’s 2025 initiatives highlight evolving pharmaceutical regulation amid digital transformation. Key discussions addressed AI-enabled Pharma 4.0 manufacturing, transportable and point-of-care production, regulatory harmonization in Latin America, and supply chain resilience. Through global workshops, panels, and training programs, ISPE continues to advance regulatory collaboration, innovation adoption, quality, and harmonized oversight worldwide.

ISPE events in 2025 highlighted evolving global pharmaceutical regulation. Sessions addressed navigating ATMP guidance differences, regulators’ adoption of digital transformation and AI, and FDA oversight strategies in China. ISPE emphasized the value of unified industry input on draft regulations and showcased regulatory leadership, including Tami Frederick’s work advancing pharmaceutical quality and continuous improvement worldwide through collaboration and education.

ISPE conferences highlighted evolving regulatory expectations across pharmaceutical manufacturing. Topics included data management and contamination control under Annex 1 for sterile manufacturing, lifecycle management and regulatory readiness for advanced therapies, FDA initiatives to elevate pharmaceutical quality through OQS and ISPE’s APQ™ program, and FDA oversight of pharmaceutical compounding shaped by safety events and statutory frameworks.

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. FDA on Regulatory Reliance and Agility Theresa Mullin, PhD, Associate...

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. FDA on AI in Pharmaceutical Manufacturing At ISPE’s 2024 Biotechnology...

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. ISPE Issues Report on Barriers to Innovation Industry reports...

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Quality Beyond CGMP: FDA Initiatives In a keynote presentation at ISPE...

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Regulators on Trust, Collaboration, Reliance, Harmonization...

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Barriers to Innovation: Your Input Requested ISPE has launched a...